Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up. Pressure ulcers
Methods/design: This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events.
Discussion: This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks.
Trial registration: This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14. Pressure ulcers
Keywords: Pressure ulcers, Pressure sore, Hydrocolloid dressing, Polyurethane foam dressings, Healing process
* Correspondence: email@example.com 1Primary Health Care-Mallorca: Research Unit. Health Care Services of Balearic Isles, IB-Salut, Palma de Mallorca, Balearic Islands, Spain Full list of author information is available at the end of the article
© 2013 Guillén-Solà et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Pressure ulcers
Guillén-Solà et al. BMC Family Practice 2013, 14:196 Page 2 of 8 http://www.biomedcentral.com/1471-2296/14/196 Pressure ulcers
Background Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues, caused by continuous pressure from friction or shearing between an external surface and a bone or cartilaginous surface. Long-standing pres- sure can reduce capillary blood flow and lead to cell death, necrosis and broken tissue, or to additional ser- ious complications, including osteomyelitis, sepsis, con- tractures, atrophy and psychological disorders [1,2]. These complications may delay mobilization and active rehabilitation, as well as reducing the ability of patients to live active and independent lives. PrUs can affect pa- tients in all health care settings, provoke pain and discom- fort, decrease quality of life and even increase morbidity and residence time in healthcare institutions [3,4]. PrUs can also increase direct and indirect healthcare
costs and provide a negative image of healthcare institu- tions, attributable to deficits in the quality of care, espe- cially since 95% of PrUs are preventable [1,2]. A national study has estimated that expenditures related to the onset of PrU amounts to approximately 5% of the annual health- care spending in Spain [3,4]. A national prevalence study in 2006 by the GNEAUPP Pressure ulcers
(Spanish acronym of National Group for the Study and Advice in Pressure Ulcers and Chronic Wounds) showed a wide variability in PrUs prevalence among types of insti- tutions. PrUs have been reported to occur in 3.73% of pa- tients in domiciliary care, 8.24% of hospitalized patients and 6.1% of patients in nursing homes. Moreover, 2.1% of patients with PrUs were aged 0 to 45 years, 6.4% were aged 46 to 64 years and 87.4% were aged ≥ 65 years . Within each category, PrU incidence was very variable, ranging from 3-29% in hospitalized patients. Moreover, PrUs have been observed in 66% of elderly individuals (risk population) with femur fractures [4-7]. The European Pressure Ulcer Advisory Panel (EPUAP) Pressure ulcers
has classified PrUs in four stages. Stages I and II are more frequent, with a combined rate of about 65% , although it differs among studies [8-15]. The EPUAP has defined stage II PrU (PrU-II) as involving a partial loss in skin thickness, affecting the epidermis and/or dermis. These are considered superficial ulcers, clinically manifesting as abrasions or blisters [8,16]. Prevention is the best treatment for PrU. However,
despite Good Clinical Practice Guidelines (GCP), [17-20] which report the effectiveness of preventive activities (adequate nutrition, effective pressure relief, positional changes, management of incontinence and elimination of shearing and friction forces), there is little scientific evidence supporting the efficacy of these measures in avoiding further problems related to PrUs [1-3]. In contrast, evidence has suggested that PrUs healing
in a moist environment, using special or modern dress- ings, is more cost effective than traditional cure or dry-to-
wet dressings (i.e. dressings that do not maintain a moist environment) because the former stimulate cell prolifera- tion. In addition, special dressings act as a barrier against bacteria, absorb excess wound fluid, reduce pain during the healing process and create the right conditions (moist environment) for healing or scarring [1,3,18-20]. The benefits of a moist environment have led to the Pressure ulcers
development of a flowering variety of synthetic dressings (special or also called modern dressings). Use of these dressings depends on the availability of resources, PrU stage and morphology, and the presence of infection and/or necrosis [1,3,18-20]. Although GCP guidelines indicate that the special
dressings most frequently used to treat PrU-II are hydro- colloid and polyurethane foam dressings. To date, how- ever, systematic reviews and clinical trials have established a poorly and scarcely evidence of their effectiveness. Al- though studies have shown benefits of polyurethane dress- ings, their benefits did not differ significantly from those of hydrocolloid dressings. In addition, these studies in- volved patients with various wound types (pressure ulcers and venous ulcers) and different PrU stages, which may have affected the results [1,3,18-21]. To overcome these limitations, the present study will Pressure ulcers
compare two types of dressings in the treatment of PrU- IIs, both which are recommended and are part of habitual clinical practice [1,3,19,20]. However, due to the wide vari- ability in both types of dressing, this study will compare the adhesive versions of polyurethane and hydrocolloid dressings.
Aim and hypothesis The main hypothesis of this study is that hydrocolloid dressings would heal at least 10% more stage II PrUs than polyurethane foam dressings over 8 weeks of follow-up in patients with PrU-II. The aim of the proposed protocol is to compare the
efficacy of adhesive polyurethane foam dressings and ad- hesive hydrocolloid dressings in the treatment of PrU-II. The primary objective will be to assess the percentage of wounds healed after 8 weeks. Secondary objectives include assessments of: Pressure ulcers
– improvements in the clinical efficacy of both dressings, as measured by ulcer area (cm ), exudates, type of tissue (PUSH Scale) and time to healing (epithelial tissue).
– treatment efficacy, as measured by PrU-II resolutionwithin study time.
– safety, as determined by adverse events (AE) attributed to both dressings.
– direct costs of both dressings, as measured by cost per healed ulcer and cost per treated patient.
Guillén-Solà et al. BMC Family Practice 2013, 14:196 Page 3 of 8 http://www.biomedcentral.com/1471-2296/14/196
– convenience of dressing use, as determined by adherence properties, management of the dressing, comfort, pain during the healing procedure, number of dressings used and perilesional skin state.
Methods and design Study design This will be a multicenter, randomized trial evaluating and comparing the efficacy of the adhesive polyurethane foam and hydrocolloid dressings in patients with PrU-II within the context of habitual prevention measures. Pressure ulcers
Setting and eligibility criteria This study will recruit patients who receive primary health assistance, including patients able to attend the primary health center or receive health assistance in homes, nursing-homes and non-acute long term hospitalization centers. Each patient must present with at least one PrU-II.
– Age ≥ 18 years. – Confirmed diagnosis of PrU-II. If a patient has more
than one PrU-II, only the largest diameter ulcer will be assessed. Other PrU-II will receive the best treatment elected by the study nurse.
– Stage I, III or IV PrU only. – Non classifiable PrU. – Surgical treatment prior to PrU and/or PrU in
previously irradiated areas. – Participation in another clinical trial within
3 months of study entry. – Allergy or hypersensitivity to materials in the study
dressings. – Signs of PrU basal infection (sepsis/bacterial),
cellulitis or osteomyelitis. Patients successfully treated for infection can be included if the PrU can be classified as stage II. Pressure ulcers
– Venous ulcers and/or diabetic feet. – Type I diabetes. – Situations of extreme severity and/or agony; e.g.
patients in terminal phase with <3 points on the Braden scale and/or a life expectancy < 1 month.
Recruitment Each primary health center or nursing home will have one or two study nurses to assess eligibility criteria, to invite potential candidates to participate in the clinical trial and to carry out all protocol procedures (see section on Interventions).
Potentially eligible patients will be recorded, as well as reasons for exclusion. All included patients will be given a patient information sheet and an informed consent form. Signing of the latter is essential for study inclusion. If a patient’s clinical condition makes signing of the in-
formed consent form impossible, a relative or guardian will be responsible for signing; however, those patients must clearly indicate orally their willingness to participate in the study. Any included patient who drops out or is lost during the Pressure ulcers
clinical trial process will be recorded on the appropriate form.
Randomization Participants will be enrolled consecutively by their study nurse. Each participating center will have a unique randomization list. This sequential randomization will be generated in blocks of 12, up to a maximum of 24 recruited patients per center (see Additional file 1: Figure S1).
Sample size Assuming that 30% of patients in the polyurethane arm will show healing of PrU-II at 8 weeks, an alpha risk of 5%, a beta risk of 20% with bilateral contrast and a loss to follow-up of 15%, 410 individuals will be required in each treatment arm to detect a ≥10% difference in healed ulcers [22,23].
Blinding Due to an inability to mask the appearance of the two dressings, it will only be possible to mask the final evalu- ation of PrU. Pressure ulcers
Interventions Participants will be randomized to hydrocolloid or polyur- ethane dressing. All patients will receive a standardized preventive intervention to reduce pressure and undergo a PrU healing cure process. Transversal interventions are designed for pressure
relief and positional changes, favoring an optimal evolu- tion of stage II PrU (PrU-II). Adequate relief of pressure forces (shearing or friction) requires changes in position of bedridden or sitting patients and the use of pressure- relieving support surfaces (PRSS). Due to their structure, PRSS can reduce pressure forces,
as well as heat and humidity, increasing patient comfort. PRSS can cover the entire body or only part of it and can be found in different sizes and types: mattresses, mats or cushions. However, it is important to highlight that the use of PRSS does not mean ignoring other healing proce- dures, including changes of position, skin care and good nutritional state. Rather, PRSS use only serves as a com- plement to the healing process .
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To standardize changes in position and pressure re- duction, study nurses will follow a national GCP rec- ommendations . Recommendations for frequency of position changes, as well as specific recommendations for bedridden and sitting patients, must be taken into account. Each study nurse or caregiver will be trained to properly implement the recommendations in the aforementioned GCP. Healing cure process addresses the cleansing process Pressure ulcers
and prevention of infection. Standardization of this process can be accomplished using recommendations from the reference GCP. Briefly:
– The wound must be cleaned every time the study dressing is changed. The first step is to thoroughly irrigate the wound bed with saline solution to remove detritus, bacteria and remains of any previous treatment. A 20 ml syringe of saline solution adapted with a 0.9 × 25 needle or a 19 mm catheter. Local antiseptics (e.g. povidone, chlorhexidine) and skin cleaners should be avoided because they are cytotoxic to new granulating tissue and their habitual use can have systemic effects due to absorption.
– The drying procedure must be also delicate. Rough material (such as gauzes or sponges) can induce small traumas on the wound bed, increasing the risk of infection and interfering with the healing process. Wound edges should be dry and clean and wound beds moist. Care should be taken to avoid damaging healthy tissue during cleansing and drying procedures. Pressure ulcers
– Bacterial infection should be prevented. An aseptic technique should be used if possible, including the use of clean gloves. Proper healing and debridement procedures can minimize the risk of infection. If a patient presents with more than one PrU-II, the most contaminated one should be left to the end (i.e. perennial area).
It is important to isolate and remove waste and contaminated materials in accordance with established precautions to avoid cross contaminations. If there is leakage of exudates, lack of adherence or
any situation suggesting loss of study dressing, additional (secondary) dressings will be used. If this additional sup- port is inadequate, the study dressing will be changed following the same procedure and be registered in the CRF. Pressure ulcers
Study dressings Polyurethane foams Description and features These dressings derive from polyurethanes and have a hydrophilic structure. They
present with a high capacity of autolytic debridement and absorption of exudates; and keep the wound bed from drying out, without leaving residuals or decomposing. In addition, they avoid leakages, stains and odors, keep periwound skin intact, reduce frictional forces and do not produce traumas when removed.
Indications These dressings are recommended for all stages of PrU (with moderate or high exudates). Frequent monitoring and changes may be necessary when PrUs become infected.
Contraindications These dressing cannot be combined with antiseptics (e.g. iodine, chlorhexidine, hypochlorite, ether or hydrogen peroxide), oxygenated water or sodium hypochlorite because all of the latter can destroy the dressing [1,3].
Hydrocolloids Description and features These dressings are made of carboxymethylcellulose (CMC) and other hydrocolloids (elastomers), adherent substances or hydroactive com- pounds, providing absorption capacity. They are covered with a polyurethane layer, giving them occlusive or semi occlusive properties. In addition, they absorb exudates and necrotic residuals by forming a gel with special color and odor characteristics, creating a slightly acid environ- ment with bacteriostatic properties. Moreover, they reduce friction forces.
Indications These dressings are recommended in non- infected PrU stages I, II and III; slough ulcers and those with necrotic tissue (as an autolytic debriding agent) and granulation phase or epithelialization healing process.
Contraindications These dressings should not be applied to infected ulcers or those in which bones or tendons are observed. Ether and aggressive antiseptics should be avoided when using these dressings [1,3]. Pressure ulcers
Variables Main outcome variables The main efficacy outcome of the study is rate of PrU-II healing or ulcer epithelialization tissue (scored on the PUSH scales as 0). Two digital photographs will be taken, one at the beginning and the other at the end of treatment, and sent to the expert panel committee from Balearic Islands (GAUPP) for evaluation. This committee will be blinded to treatments of individual patients.
Secondary outcome variables Efficacy Changes in the basal PUSH scale, [24-27] ulcer area (in cm ) at the end of treatment, exudates and tissue type Pressure ulcers